Ultrasound Guided : Retrolaminar Block Versus Thoracic Epidural Analgesia for Pain Control Following Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Pain intensity at rest and at cough using Numerical Rating Scales (NRS)
研究概览
简要总结
The aim of this study is to evaluate analgesic effect of ultrasound-guided retrolaminar block vs ultrasound-guided thoracic epidural analgesia in pain control following laparoscopic cholecystectomy.
详细描述
To study the difference between the effects of ultrasound-guided bilateral retrolaminar block and ultrasound-guided thoracic epidural analgesia on pain control following laparoscopic cholecystectomy. To relief pain and improve satisfaction in patients undergoing laparoscopic cholecystectomy at Zagazig university hospitals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Double (participant, outcomes assessor) Anesthetist not sharing in the study will assess patient.
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent from the patient.
- •Age: 21-45 years old.
- •Sex: both sex (males and females).
- •Physical status: ASA 1& II.
- •BMI = (25-35 kg/m2).
- •Type of operation: elective laparoscopic cholecystectomy
排除标准
- •Altered mental state.
- •Patients with known history of allergy to study drugs.
- •Advanced hepatic, renal, cardiovascular, and respiratory diseases.
- •Patients with chronic pain.
- •Patients receiving anticoagulants.
- •Contraindications of regional anesthesia, e.g., allergy to local anesthetics, coagulopathy, or septic focus at site of injection.
研究组 & 干预措施
group T
Group (T) (n=26): will receive ultrasound guided thoracic epidural analgesia: 20 ml of bupivacaine 0.25 % plus 5ug/ml adrenaline (1:200000).
干预措施: Thoracic epidural analgesia (Procedure)
group R
Group (R) (n=26): will receive bilateral ultrasound guided retrolaminar block analgesia: 20 ml of bupivacaine 0.25 % plus 5ug/ml adrenaline (1:200000).
干预措施: Bilateral retrolaminar block (Procedure)
结局指标
主要结局
Pain intensity at rest and at cough using Numerical Rating Scales (NRS)
时间窗: at 12 hours postoperative
measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain)
Pain intensity at rest and at cough using Numerical Rating Scales (NRS)
时间窗: 30 minutes postoperative
measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain)
Pain intensity at rest and at cough using Numerical Rating Scales (NRS)
时间窗: at 1 hour postoperative
measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain)
Pain intensity at rest and at cough using Numerical Rating Scales (NRS)
时间窗: at 2 hours postoperative
measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain)
Pain intensity at rest and at cough using Numerical Rating Scales (NRS)
时间窗: at 4 hours postoperative
measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain)
Pain intensity at rest and at cough using Numerical Rating Scales (NRS)
时间窗: at 6 hours postoperative
measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain)
Pain intensity at rest and at cough using Numerical Rating Scales (NRS)
时间窗: at 8 hours postoperative
measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain)
Pain intensity at rest and at cough using Numerical Rating Scales (NRS)
时间窗: at 10 hours postoperative
measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain)
次要结局
- Total analgesic (Naluphine) consumption(within 12 hours postoperative)
- Time to first call of rescue analgesia(within 12 hours postoperative)
- The number of participant with nausea, vomiting, hypotension and bradycardia.(24 hours postoperative)
- The number of participant with complications of the techinque (dural puncture , nerve injury, spinal injection, epidural haematoma, pleural puncture)(within 24 hours postoperative)
- Patient satisfaction is recorded at the end of 24 hours postoperative(24 hours postoperative)
研究者
Dina Abdelhameed Elsadek Salem
Principle investigator
Zagazig University